FORM 2
THE PATENT ACT 1970 (39 of 1970)
&
The Patents Rules, 2003 COMPLETE SPECIFICATION
(See Section 10, and rule 13)
1. TITLE OF INVENTION
AN APPARATUS FOR PREPARING HAEMODIALYSIS CONCENTRATES IN HAEMODIALYSIS DEPARTMENTS
2. APPLICANT(S)
a) Name : ATLANTIC BIOMEDICAL PVT. LTD.
b) Nationality : INDIAN Company
c) Address : 101, BUSINESS POINT 349,
WESTERN EXPRESS HIGHWAY, ANDHERI (EAST), MUMBAI-400 069, MAHARASHTRA, INDIA
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is" to be performed : -

Field of the Invention:
The present invention relates to Haemodialysis Concentrates. Particularly it relates to a device for making the Haemodialysis Concentrates.
Prior Art:
In medicine, dialysis is primarily used to provide an artificial replacement for lost kidney function (renal replacement therapy) due to renal failure. Dialysis may be used for very sick patients who have suddenly but temporarily, lost their kidney function (acute renal failure), or for quite stable patients who have permanently lost their kidney function (stage 5 chronic kidney disease).
For patients with stage 5, or End-Stage Kidney Disease (ESKD), the decline in kidney function occurred over a period of months to years until a level was reached at which treatment was needed for survival. Unlike Acute Renal Failure (ARF) (Acute Kidney Injury (AKI)), Chronic Kidney Failure cannot be cured or reversed and long-term treatments are needed to replace the lost functions of the kidney. The treatment for ESKD that most naturally replaces lost kidney function is a kidney transplant. However, some patients are not good candidates for a transplant due to medical or other reasons, some cannot receive a transplant because of the short supply of donor kidneys, and others simply decide that a transplant is not the best option for them. As a result, most patients with ESKD must rely on dialysis to replace the water and waste removal functions of the healthy kidneys.
The kidneys have important roles in maintaining health. When healthy, the kidneys maintain the body's internal equilibrium of water and minerals (sodium, potassium, -chloride, calcium, phosphorus, magnesium, sulfate). Those acidic metabolism end products that the body cannot get rid of via respiration are also excreted through the kidneys. The kidneys also function as a part of the endocrine system producing erythropoietin and 1,25-dihydroxycholecalciferol (calcitriol). Erythropoietin is

involved in the production of red blood cells and calcitriol plays a role in bone formation. Dialysis is an imperfect treatment to replace kidney function because it does not correct the endocrine functions of the kidney. Dialysis treatments replace some of these functions through diffusion (waste removal) and ultrafiltration (fluid removal).
Dialysate is one of the two fluids used in dialysis. The other fluid being blood. The term dialysate refers to fluids and solutes which have crossed a membrane. The main function of the dialysate, is to remove waste material from the blood and to keep useful material from leaving the blood. Electrolytes and water are some materials included in the dialysate so that their level in the blood can be controlled. The makeup of dialysate or the dialysis 'bath', is: sodium chloride, sodium bicarbonate or sodium acetate, calcium chloride, potassium chloride, and magnesium chloride. This is the general composition of dialysate, but other compounds such as glucose may also be included. Glucose is sometimes included.
Several devices/ machines are available for making such Haemodialysis . Concentrates. However these device/machines are suffering from following deficiencies:
i. They don't have online pH and conductivity sensing & thereby no built-in
safety features, ii. They are unable to make accurate dialysis solution, iii. They are semiautomatic. iv. They require human intervention, v. They require manual cleaning, vi. They are not reliable.
Hence there is an urgent need to take a call upon development of the new device or machine which can take care of aforesaid deficiencies.

Object of the Invention:
The' main object of the present invention is to provide an apparatus for preparing Haemodialysis Concentrates, in Haemodialysis Departments which is devoid of human error.
Another object of the invention is to provide the apparatus for preparing Haemodialysis Concentrates which ensures safety by checking online pH and conductivity thereby
Yet another object of the invention is to provide the apparatus for preparing Haemodialysis Concentrates which is accurate and speedy.
Yet another object of the invention is to provide the apparatus for preparing Haemodialysis Concentrates which can operate both manually as well as automatically.
Yet another object of the invention is to provide the apparatus for preparing Haemodialysis Concentrates which is compact and easy to maintain.
Summary of the Invention:
Accordingly to achieve the aforesaid objects the present invention provides an apparatus for preparing Haemodialysis Concentrates, the apparatus comprising:
mixing unit for mixing Haemodialysis Concentrate in powder form and water to prepare Haemodialysis Concentrates;
first sensing unit for sensing pH and conductivity of the Haemodialysis Concentrates;

second sensing unit for sensing the level of the water or the Haemodialysis Concentrates in the mixing unit;
pump and valve assembly in fluid communication with the mixing unit, the pump and valve assembly adapted for the purpose of water filling, mixing, rinsing and draining of the water or the Haemodialysis Concentrates; and
control unit operationally connected to the mixing unit, first sensing unit, second sensing unit and pump and valve assembly, the control unit being configured for:
- controlling preparation of the Haemodialysis Concentrates in the mixing unit,
- comparing pH and conductivity of the Haemodialysis Concentrates with predetermined values,
- controlling water level inside the mixing unit using output of the second sensing unit,
- controlling automatic cleaning of the mixing unit, and
- controlling the pump and valve assembly as per the activity of water filling, mixing, rinsing and draining of the water or the Haemodialysis Concentrates.
According to an embodiment of the invention, the medicinal solutions are Haemodialysis Concentrates. The Haemodialysis Concentrates can be either Acid Concentrate or Bicarbonate Concentrate.
According to another embodiment of the invention the first sensing unit comprises pH meter and conductivity meter.

Brief Description of the Drawings:
Fig. 1 : Shows perspective view of an apparatus for preparing
Haemodialysis Concentrates in accordance to present invention.
Fig. 2 : Shows detailed view of the apparatus of figure 1.
Fig. 3 : Shows perspective view of the control unit.
Detailed Description of the Drawings:
The features, nature, and advantages of the disclosed subject matter will become more apparent from the detailed description set forth below when taken in conjunction with the drawings in which like reference numerals identify correspondingly throughout.
Referring to figure 1, an apparatus for preparing Haemodialysis Concentrates of the present invention is illustrated. The apparatus mainly includes mixing unit (T), pH meter (PHM), conductivity meter (CM), level sensor (LS), pump and valve assembly (PVA) and control unit (CU).
The mixing unit (T) mixes Haemodialysis Concentrate in powder form and water to prepare Haemodialysis Concentrates. The mixing unit comprises pH meter (PHM) for measuring pH of the solution and conductivity meter (CM) for measuring conductivity of the solution. The level sensor (LS) is provided inside the mixing unit (T) for sensing the level of the water or the Haemodialysis Concentrates in the mixing unit (T). The system has different levels like 80 liters, 160 liters and etc. All these sensors (PHM, CM, LS) are attached to the control unit (CU). The output of these sensors is given to control unit (CU) and accordingly apparatus operates.

Every batch is validated by these sensors and the apparatus, gives warning if any of the value deviates from standard value.
The pump and valve assembly (PVA) are connected to the mixing unit (T) in fluid communication. The pump and valve assembly (PVA) adapted for the purpose of water filling, mixing, rinsing and draining of the water or the Haemodialysis Concentrates. Figure 2 shows detailed illustration of the pump and valve assembly (PVA). The pump and valve assembly (PVA) includes pump (P) and valves (V1, V2, V3, V4, V5, V6, V7). The pump and valves function as follow:
i. Water filling: P, V1, V2 ii. Mixing: P, V4, V5 iii. Rinsing: P, V1, V3 iv. Draining/filling: P, V6, V7.
The control unit (CU) is operationally connected to the mixing unit (T), sensors (PHM, CM, LS) and pump and valve assembly (PVA). The control unit (CU) controls preparation of the Haemodialysis Concentrates in the mixing unit (T). The control unit (CU) compares pH and conductivity of the Haemodialysis Concentrates with predetermined values. It also controls water level inside the mixing unit (T) using output of die level sensor (LS). The control unit further controls the pump and valve assembly (PVA) as per the activity of water filling, mixing, rinsing and draining of the water or the Haemodialysis Concentrates.
Referring to figure 3, the control unit (CU) includes a processor, memory, display and input means. The display is adapted for showing various kinds of data relating to Haemodialysis Concentrates preparation. For example the data may include mode of system either automatic or manual, values of ph, conductivity etc. The input means provides platform to the user for inputting the required data relating to Haemodialysis Concentrates preparation. The input means may include keyboard or the like. The processor is adapted for processing various kinds of data received from

the various sensors and other processing task like comparing of data etc. relating to Haemodialysis Concentrates preparation. The memory stores the data. The display, input means and memory are operatively connected to the processor.
The mixing unit (T) has two modes of operation one is fully automatic and other is manual. If the automatic system fails, manual mode helps to prepare batches to make system uptime 100%. For manual mode, the mixing unit (T) comprises manual inlet (M in) for filling of the water inside the mixing unit (T). The manual filling is also provided through valve V7. There is an arrangement of filter (F) for the filtration of the water.
The apparatus of the present invention has also a provision for automatic cleaning. The automatic cleaning is controlled by the control unit (CU). The mixing unit (M) gets cleaned every time before preparing every batch of Haemodialysis Concentrates.
Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the . invention. It is to be understood that the forms of the invention shown and described herein are to be taken as the presently preferred embodiments. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements described herein without departing from the spirit and scope of the invention as described in the following claims.

WE CLAIM:
1, An apparatus for preparing Haemodialys is Concentrates, the apparatus comprising:
mixing unit (T) for mixing medicinal powder and water to prepare Haemodialysis Concentrates.
first sensing unit (PHM, CM) for sensing pH and conductivity of the Haemodialysis Concentrates;
second sensing unit (LS) for sensing the level of the water or the Haemodialysis Concentrates in the mixing unit (T);
pump and valve assembly (PVA) in fluid communication with the mixing unit (T), the pump and valve assembly (PVA) adapted for the purpose of water filling, mixing, rinsing and draining of the water or the Haemodialysis Concentrates; and
control unit (CU) operationally connected to the mixing unit (T), first sensing unit (PHM, CM), second sensing unit (LS) and pump and valve assembly . (PVA), the control unit (CU) being configured for:
- controlling preparation of the Haemodialysis Concentrates in the
mixing unit (T),
comparing pH and conductivity of the Haemodialysis Concentrates with predetermined values,
- controlling water level inside the mixing unit (T) using output of the second sensing unit,
- controlling automatic cleaning of the mixing unit (T), and controlling the pump and valve assembly (PVA) as per the activity of water filling, mixing, rinsing and draining of the water or the Haemodialysis Concentrates.

2. The apparatus for preparing medicinal solution as claimed in claim 1 wherein the medicinal solution is Haemodialysis Concentrate.
3. The apparatus for preparing medicinal solutions as claimed in claim 2 wherein medicinal solution is haemodialysis concentrates.
4. The apparatus for preparing Haemodialysis Concentrates as claimed in claim 2 wherein Haemodialysis Concentrates are Acid and Bicarbonate concentrates.
5. The apparatus for preparing Haemodialysis Concentrates as claimed in claim 1 wherein the first sensing unit (PHM, CM) comprises pH meter (PHM) and conductivity meter (CM).